QA Lab Specialist - ISO/GMP, Data-Driven Quality

Filtration Group; Louisville (CO); On-site; USD 60,000 - 65,000; Full time

Benefits offered by this job

Family leave

Health and wellness benefits

Health insurance

Paid Parental Leave

401k with Company Matching

Job summary

Molecular Products, Inc. is seeking a Quality Assurance Lab Specialist in the Louisville/Denver area to perform QA tests, manage toxic gases, and operate GC equipment while ensuring compliance with FDA, GMP, and ISO standards in a laboratory setting.

The role requires a science degree, QA lab experience, and strong analytical skills. Proficiency in MS Office, safety awareness, and clear communication are essential. Benefits include health insurance, 401k with company matching, and parental leave.

Qualifications

• Bachelor’s degree in science, chemistry, bio-chemistry, chemical engineering, related or equiv. QA laboratory experience.
• Strong analytical and problem-solving skills.
• Safety oriented.
• Knowledge of ISO 9001 and/or ISO 13485 Quality Management System Requirements
• MS Office - Beginner to intermediate knowledge in Word, Excel and Access
• Excellent written and verbal communication skills

Responsibilities

• Performs quality control tests following procedures including adsorbent performance using challenge gases, toxic gases.
• Tracks and handles toxic gases in compliance with local laws and regulations, including the shipping and receiving of items.
• Operate GC’s and associated equipment for the physical properties (moisture content, particle size distribution, apparent density)
• Must be comfortable performing statistical data analysis, maintaining test control charts
• Follows process workflow and safety guidelines and protocols.
• Ability to complete basic preventive maintenance, equipment cleaning, work space cleaning, equipment calibration as required
• Ability to create lab scale sample generation.
• Ensure compliance with company policies and business practices including FDA Regulations, GMP, and ISO Medical Device Quality System Requirements.
• Investigate and troubleshoot product or production issues
• Develop corrective actions, solutions and improvements when necessary.
• Comfortable working in a lab environment.
• Computer skills are a must as well as detail oriented.
• Final Product Release – review final product data for conformance to requirements.
• Incoming Inspection – sample and inspect incoming material for conformance to requirements
• Manage Non-conforming material and deviations for assigned products.
• Reports on product performance trends proactively.
• Other duties as assigned

Skills

Analytical skills

Problem solving

Safety oriented

Written & verbal communication

Education

Bachelor’s degree in science/chemistry/biochemistry/chemical engineering

Tools

MS Office (Word, Excel, Access)

Job description

Molecular Products, Inc. is seeking a Quality Assurance Lab Specialist in the Louisville/Denver area to perform QA tests, manage toxic gases, and operate GC equipment while ensuring compliance with FDA, GMP, and ISO standards in a laboratory setting.

The role requires a science degree, QA lab experience, and strong analytical skills. Proficiency in MS Office, safety awareness, and clear communication are essential. Benefits include health insurance, 401k with company matching, and parental leave.